The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-10-31

Brief Summary

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The purpose of this trial is to determine the effect of raltegravir on pravastatin pharmacokinetics and vice versa by intrasubject comparison.

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Detailed Description

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Pravastatin is a first choice statin for HIV-infected patients. Therefore, raltegravir and pravastatin are expected to be co-administered frequently in HIV-infected patients.Since both agents share the same metabolic pathway, there is a potential for a pharmacokinetic drug-drug interaction.

Because co-administration will be indicated in many HIV-infected patients, it is essential to investigate this potential interaction.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Pravastatin 40 mg QD for 4 days

Group Type ACTIVE_COMPARATOR

Pravastatin

Intervention Type DRUG

40 mg tablet; QD; 4 days

B

Raltegravir 400mg BD for 4 days

Group Type ACTIVE_COMPARATOR

Raltegravir

Intervention Type DRUG

400mg tablet; BD 4 days

C

Interaction between pravastatin and raltegravir

Group Type EXPERIMENTAL

Pravastatin and raltegravir

Intervention Type DRUG

pravastatin 40mg tablet QD for 4 days; raltegravir 400mg tablet BD for 4 days

Interventions

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Pravastatin

40 mg tablet; QD; 4 days

Intervention Type DRUG

Raltegravir

400mg tablet; BD 4 days

Intervention Type DRUG

Pravastatin and raltegravir

pravastatin 40mg tablet QD for 4 days; raltegravir 400mg tablet BD for 4 days

Intervention Type DRUG

Other Intervention Names

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Selektine Isentress Selektine and Isentress

Eligibility Criteria

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Inclusion Criteria

* Subject is at least 18 and not older than 55 years of age.
* Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day.
* Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2.
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
* Subject is in good age-appropriate health condition.
* Subject has a normal blood pressure and pulse rate.

Exclusion Criteria

* Documented history of sensitivity/idiosyncrasy to medicinal products or exci-pients.
* Positive HIV test.
* Positive hepatitis B or C test.
* Pregnant female or breast-feeding female.
* Therapy with any drug.
* Relevant history or presence of pulmonary disorders (especially COPD), car-diovascular disorders, neurological disorders (especially seizures and mi-graine), gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
* Fasting triglyceride levels \> 8.0 mmol/L
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* History of or current abuse of drugs, alcohol or solvents.
* Inability to understand the nature and extent of the trial and the procedures required.
* Participation in a drug trial within 60 days prior to the first dose.
* Donation of blood within 60 days prior to the first dose.
* Febrile illness within 3 days before the first dose

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes